LCP 423.407Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982215963), received between Mar 19, 2024 and Nov 15, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 15, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN OSTEOSYNTHESIS SURGERY FOR FRACTURE OF THE LEFT RADIUS OF THE DIAPHYSIS WITH THE PRODUCTS IN QUESTION. IN THE SURGERY, THE LOCKING SCREW SLEEVE COULD NOT BE SUCCESSFULLY INSTALLED INTO THE HOLE AT THE END. THE LOCKING SCREW COULD BE INSERTED BUT THE FINAL FASTENING WAS NOT POSSIBLE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 20695684 ↗
• MalfunctionApr 18, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) SURGERY FOR A DIAPHYSEAL FRACTURE OF THE ULNA. THE SURGEON TRIED TO PASS A 1.5MM K-WIRE THROUGH THE HOLE IN THE PLATE FOR TEMPORARY FIXATION, BUT THE K-WIRE DIDN¿T ADVANCE EASILY. INITIALLY, THE SURGEON WAS AWARE THAT THE K-WIRE WOULD NOT PASS THROUGH THE HOLE BECAUSE OF THE PATIENT'S STIFF BONE, BUT THE K-WIRE BROKE OFF DURING THE PROCEDURE. WHEN THE PLATE WAS TAKEN OUT AND CHECKED, THE K-WIRE WAS STUCK IN THE HOLE IN THE PLATE AND COULD NOT BE REMOVED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. PATIENT IS LISTED AS STABLE AND NO MEDICAL INTERVENTION WAS REQUIRED. THE SURGERY WAS COMPLETED WITH ALTERNATE IMPLANT FIXATION. NO FRAGMENTS REMAINED IN THE PATIENT. THE SURGEON CONFIRMED BY X-RAY. THIS REPORT IS FOR ONE TI LCP® METAPHYSEAL PLATE 7 HOLES STERILE FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19135118 ↗
• InjuryMar 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON UNKNOWN DATE, THE PATIENT UNDERWENT AN OSTEOSYNTHESIS FOR A RADIAL DIAPHYSEAL FRACTURE. AFTER THE SURGERY, A FRACTURE OCCURRED IN THE MOST PROXIMAL POSITION OF THE SCREW. A REVISION SURGERY IS SCHEDULED FOR (B)(6), 2024. IN THE REVISION SURGERY, IMPLANTS WILL BE REMOVED, AND AN OSTEOSYNTHESIS WILL BE PERFORMED AGAIN WITH A PLATE. THE INITIAL SURGERY WAS PERFORMED APPROXIMATELY 5 YEARS AGO. THE FRACTURE TREATED IN THE INITIAL SURGERY HAS ALREADY ACHIEVED BONE UNION. THE FRACTURE THIS TIME OCCURRED WHILE PLAYING RUGBY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE LCP METAPHYSPL 3.5 7HO L99 TI. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 18932876 ↗